Models 2200DR and 1600DR Digital Stationary Radiographic Systems— 510(k) K151219
Substantially EquivalentBeijing Polycon Medical Engineering Company
FDA 510(k) clearance K151219 for Models 2200DR and 1600DR Digital Stationary Radiographic Systems, Substantially Equivalent on 2015-08-04. Applicant: Beijing Polycon Medical Engineering Company.
Clearance details
- Applicant
- Beijing Polycon Medical Engineering Company
- Product code
- Code KPR
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Beijing, CN
Adverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.